Senior Process Sciences Engineer – AAV Fill/Finish, MSAT

Encoded Therapeutics Inc.

Morrisville (NC)

On-site

USD 150,000 - 190,000

Full time

3 days ago
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Benefits offered by this job

Stock options
PTO & holidays
Parental leave
Pre-tax benefits
Wellness resources
Professional development
Team-building events
Stocked kitchen

Job summary

Encoded Therapeutics is seeking an experienced engineer to own clinical, PPQ, and commercial Drug Product manufacturing for AAV products. You will lead tech transfer, collaborate across URS development, vendor selection, and CQV strategies, and provide in-plant support at multiple sites.

The role requires strong cGMP knowledge and the ability to drive complex fill/finish programs. Ideal candidates have a BS/MS in biochemical/chemical engineering or related fields, 10+ years in MSAT/Process

Qualifications

  • BS/MS in biochemical/chemical engineering or related field.
  • 10+ years industry experience; MSAT/PD/Process Sciences preferred.
  • Experience with sterile fill-finish and aseptic processing.
  • Strong knowledge of cGMP and regulatory expectations.

Responsibilities

  • Own clinical, PPQ, and commercial Drug Product manufacturing for AAV products.
  • Lead internal and external Tech Transfer for Drug Product manufacturing.
  • Collaborate on URS development, vendor selection, and FAT/SAT for Fill/Finish facilities.
  • Develop CQV protocols and equipment validation strategies.
  • Provide in-plant GMP support at multiple sites and for regulatory inspections.
  • Develop and maintain manufacturing performance trending tools.
  • Support tech transfer business processes with tools/templates.

Skills

MSAT/PD/Process Sciences
Fill/Finish operations
cGMP knowledge
Sterile processing
Cross-functional collaboration
Study design & analysis
Regulatory support & inspections
Vendor selection & tech transfer

Education

BS/MS in biochemical/chemical engineering or related field

Job description

Encoded Therapeutics is seeking an experienced engineer to own clinical, PPQ, and commercial Drug Product manufacturing for AAV products. You will lead tech transfer, collaborate across URS development, vendor selection, and CQV strategies, and provide in-plant support at multiple sites.

The role requires strong cGMP knowledge and the ability to drive complex fill/finish programs. Ideal candidates have a BS/MS in biochemical/chemical engineering or related fields, 10+ years in MSAT/Process

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